Clinical Trial Deaths And Compensation In India // Pharmalot

An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes.

And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials.

A Novartis spokesperson tells the paper that its clinical trial investigator insisted any deaths were not caused by a medication, but instead due to the progression of underlying diseases. And compensation is not required in such cases. Other drugmakers offered a similar argument. Ministry officials also say that most deaths, which were attributed to cancer or cardiovascular and cerebrovascular disorders, seemed to have occurred due to the advanced stage of illness among volunteers.

via pharmalot.com

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Medical News: Supreme Court Sides With Vaccine Maker - in Washington-Watch, Washington Watch from MedPage Today

The Supreme Court has ruled 6-3 that a federal law shields drug companies from being sued over injuries caused by childhood vaccines.

The case was brought by the parents of Hannah Bruesewitz, now a young adult, and charges that she developed a seizure disorder after receiving her third dose of the diphtheria-tetanus-pertussis (DTP) vaccine when she was 6 months old. She has suffered developmental problems ever since, and will likely require medical attention for the rest of her life, her parents say.

The dose of the vaccine in question, TRI-IMMUNOL, came from a lot that generated 65 reports of adverse reactions, including 39 emergency room visits, six hospitalizations, and two deaths, according to documents from the U.S. appeals court that heard the case in 2009.

The National Childhood Vaccine Injury Act of 1986 created a so-called "vaccine court" to address safety claims in an attempt to ease the threat of lawsuits in state courts against pharmaceutical companies and insure against them pulling out of what they claim is an unprofitable vaccine marketplace completely.

Under the law, people injured by vaccines are eligible for compensation for medical care, rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity; pain and suffering; and $250,000 for vaccine-related deaths.

via medpagetoday.com

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